UNKNOWN COOLSCULPTING® SYSTEM
Report
- Report Number
- 3007215625-2021-02111
- Event Type
- Injury
- Date Received
- December 5, 2021
- Date of Event
- April 13, 2016
- Report Date
- September 22, 2022
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K160259
- Removal / Correction Number
- 90331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA IS CHARACTERIZED BY A VISIBLY ENLARGED TISSUE VOLUME WITHIN THE TREATMENT AREA, WHICH MAY DEVELOP TWO TO FIVE MONTHS AFTER TREATMENT. SURGICAL INTERVENTION MAY BE REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.
H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-02111-00.
FDA SUBMISSION MW5111238. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) IS CHARACTERIZED BY A VISIBLY ENLARGED TISSUE VOLUME WITHIN THE TREATMENT AREA, WHICH MAY DEVELOP TWO TO FIVE MONTHS AFTER TREATMENT. SURGICAL INTERVENTION MAY BE REQUIRED. PAH IS NOT RELATED TO ANY COOLSCULPTING DEVICE FAILURE MODE BUT IT IS OBSERVED MORE FREQUENTLY WITH THE PARALLEL PLATE APPLICATORS. PAH IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE AS AN INHERENT RISK TO THE USE OF CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED. ZELTIQ INITIATED A VOLUNTARY DISCONTINUATION AND RECALL OF PARALLEL PLATE APPLICATORS FOR THE COOLSCULPTING® SYSTEM DUE TO THE OBSERVANCE OF AN INCREASED RATE OF PARADOXICAL HYPERPLASIA (PH) ASSOCIATED WITH THESE APPLICATORS DURING A RECENT ANALYSIS OF DATA FROM THE 2019-2021 TIMEFRAME. THESE APPLICATORS ARE SOLD UNDER THE BRAND NAMES COOLCORE, COOLCURVE, COOLCURVE+, COOLMAX AND COOLFIT. H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF PREVIOUS MEDWATCH REPORT A CORRECTION WAS NOTED THAT THIS IS NOT A DUPLICATE REPORT AND PREVIOUS SUPPLEMENTAL MEDWATCH REPORT CAN BE DISREGARDED.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO WAS TREATED WITH COOLSCULPTING AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA.
A TREATMENT PROVIDER REPORTED THAT A PATIENT TREATED TO WITH COOLSCULPTING] ON 2016 AND HAD NO RESULTS, ALL AREAS GOT BIGGER.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED ABDOMEN, FLANKS, AND UPPER BACK ON (B)(6) 2016, (B)(6) 2016, (B)(6) 2016 WITH COOLSCULPTING COOLMAX, COOLCORE, AND COOLCURVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED WITH PAH ON (B)(6) 2021 BY MEDICAL DOCTOR. DUE TO INSUFFICIENT INFORMATION, DEVICE INFO IS NOT DOCUMENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1829237 | UNKNOWN COOLSCULPTING® SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |